BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer
1 other identifier
interventional
550
14 countries
62
Brief Summary
The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2026
Longer than P75 for phase_3
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedStudy Start
First participant enrolled
August 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
September 17, 2026
September 1, 2026
3.4 years
May 21, 2026
September 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression, as assessed by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause, whichever occurs first.
Up to approximately 2 years
Secondary Outcomes (11)
Overall Survival (OS)
Up to approximately 2 years
Participants with Serious Adverse Events (SAEs)
Up to approximately 5 years
Participants with treatment-emergent adverse events (TEAEs)
Up to approximately 5 years
Evaluate the safety of BL-M14D1 in combination with atezolizumab
Up to approximately 5 years
Participants with abnormal lab results
Up to approximately 5 years
- +6 more secondary outcomes
Study Arms (3)
Arm A
EXPERIMENTALBL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
Arm B
EXPERIMENTALBL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
Arm C
ACTIVE COMPARATORMedications used in the Control Arm should be administered per local label or institutional guidelines. Induction therapy (4 cycles): Carboplatin (AUC of 5 mg/mL\*min IV) on Day 1 of each 21-day cycle Etoposide (100 mg/m2 IV) on Days 1 through 3 of each 21-day cycle Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Maintenance therapy (continues until discontinuation criteria are met): Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Lurbinectedin (3.2 mg/m2) IV on Day 1 of each 21-day cycle (to be added only if approved in region and as per PI discretion)
Interventions
BL-M14D1 administered in combination with atezolizumab. BL-M14D1 will be given intravenously at the protocol-specified dose and schedule. Atezolizumab will be administered intravenously according to the approved dosing regimen.
Carboplatin and etoposide will be administered intravenously in combination with atezolizumab for induction therapy, followed by maintenance treatment with atezolizumab with or without lurbinectedin per protocol.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)
- Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.
- At least one measurable lesion based on RECIST v1.1 per investigator assessment.
- An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
- Adequate organ function
You may not qualify if:
- Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.
- Participants who have received prior topoisomerase inhibitor-based ADC therapy.
- Participants with history of severe heart disease
- Participants with active autoimmune diseases and inflammatory diseases,
- Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SystImmune Inc.lead
Study Sites (62)
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Los Alamitos Hematology/Oncology Medical Group
Glendale, California, 91203, United States
MemorialCare Todd Cancer Institute
Long Beach, California, 90806, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Total Health and Research Center
Miami, Florida, 33176, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Tasman Oncology
Southport, Queensland, 4215, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
MHAT Dr. Tota Venkova
Gabrovo, 5300, Bulgaria
MHAT Heart and Brain
Pleven, 5800, Bulgaria
Medical Centre FutureMeds
Plovdiv, 1431, Bulgaria
MHAT Pulmed
Plovdiv, 4002, Bulgaria
UMHAT Sveti Ivan Rilski
Sofia, 1431, Bulgaria
MHAT Serdikamed
Sofia, 1632, Bulgaria
Arthur Child Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
University of Sherbrooke
Greenfield Park, Quebec, J4V 2H1, Canada
Nemocnice České Budějovice, a.s.
České Budějovice, 370 01, Czechia
Nemocnice Agel Vítkovice
Ostrava, 703 00, Czechia
Fakultní nemocnice Ostrava (FN Ostrava)
Ostrava-Poruba, 708 52, Czechia
Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center)
Créteil, 94010, France
CLB - Centre Léon Bérard
Lyon, 69008, France
IPC - lnstitut Paoli-Calmettes
Marseille, 13273, France
Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC)
Paris, 75005, France
ICO - L'Institut de Cancérologie de L'Ouest
Saint-Herblain, 44805, France
LTD High Technology Hospital Medcenter
Tbilisi, 0114, Georgia
Ltd New Hospitals
Tbilisi, 0114, Georgia
Pineo Medical Ecosystem LtD
Tbilisi, 0114, Georgia
LLC Todua Clinic
Tbilisi, 0119, Georgia
The First Medical Clinic LLC
Tbilisi, 0180, Georgia
Caucasus Medical Centre
Tbilisi, 0186, Georgia
Lungenklinik/Lungenkrebszentrum Köln-Merheim
Cologne, 51109, Germany
KEM | Evangelische Kliniken Essen Mitte gGmbH
Essen, 45136, Germany
Krankenhaus Martha-Maria Halle-Dölau
Halle, 06120, Germany
Henry Dunant Hospital Center
Athens, 11526, Greece
Theageneio Anticancer Hospital
Thessaloniki, 54639, Greece
St Luke's Hospital
Thessaloniki, 55236, Greece
European Interbalkan Medical Center
Thessaloniki, 57001, Greece
Semmelweis University Department of Pulmonology
Budapest, 1083, Hungary
Mátrai Gyógyintézet
Gyöngyös, 7151, Hungary
Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center
Kecskemét, 6000, Hungary
Református Pulmonológiai Intézet
Törökbálint, 2045, Hungary
Centro di Riferimento Oncologico
Aviano, 33081, Italy
Policlinico Paolo Giaccone University Hospital
Palermo, 90127, Italy
Regina Elena Institute for Cancer Research
Roma, 00144, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
AOUS Le Scotte, UOC Immunoterapia Oncologica
Siena, 53100, Italy
Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych
Bialystok, 15-540, Poland
Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii Klinicznej
Gdynia, 81-519, Poland
Oddzial Onkologii Klinicznej
Katowice, 40-514, Poland
Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii
Lodz, 93-338, Poland
Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii
Prabuty, 82-550, Poland
University Clinical Centre of Serbia, Clinic for pulmonology
Belgrade, 11000, Serbia
University Hospital Medical Center Bezanijska Kosa
Belgrade, 11000, Serbia
University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Institute for pulmonary diseases of Vojvodina
Novi Sad, 21208, Serbia
Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa Herrera
A Coruña, 15006, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Centro de Investigación Oncológica Clara Campal
Madrid, 28050, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Junliang Cai, MD
SystImmune Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinded Independent Central Review (BICR)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2026
First Posted
June 4, 2026
Study Start
August 4, 2026
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
June 1, 2031
Last Updated
September 17, 2026
Record last verified: 2026-09